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Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

ConditionTotal Thyroidectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone.

The main questions it aims to answer are:

Will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy?

Will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy?

Will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy?

Will neck massage, stretches and pain science education improve quality of life after total thyroidectomy?

Participants will:

Participate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests.

Participate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery.

Complete a journal of the participant's Home Exercise Practice

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The study population consists of individuals with malignant or benign thyroid disease scheduled to undergo total thyroidectomy

native speakers of English

All patients will be greater than or equal to 18 years of age

Disqualifiers

Participants will be excluded if they have completed voice therapy prior

are current smokers

have organic vocal fold pathology or clear mucosal changes to the vocal folds that can affect vibration (e.g., vocal fold scar, polyp, or nodules),

pre-existing unilateral or bilateral vocal fold paralysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anterior Neck Manual Therapy

    Behavioral

    Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.

  • Pain Neuroscience Education

    Behavioral

    Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.

  • Neck Stretches

    Behavioral

    Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.

  • Scar massage

    Behavioral

    Digital manipulation of the scar itself in circles.

  • Voice Exercises

    Behavioral

    Stemple Voice Exercises

  • Placebo Anterior Neck Manual Therapy

    Behavioral

    Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.

  • Placebo Pain Neuroscience Education

    Behavioral

    Will discuss how pain will as a result of the surgical intervention.

  • Placebo Neck Stretches

    Behavioral

    Will ask patient to look down as a neck stretch held for 20 seconds x3.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage ArmActive comparator 5 interventions
Group B: Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain EducationPlacebo comparator 5 interventions

Trial outcomes

Primary outcomes

1

Acoustic measures of voice clarity

Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.

Time frame
Baseline, 1 year
2

Acoustic measures of speaking voice pitch

Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.

Time frame
Baseline, 1 year
3

Acoustic measures of speaking voice quality subjectively

Clinicians will rate each patient's voice as having or not having each of the following perceptual qualities: Grade, Roughness, Asthenia, Breathiness, Strain. The scale is as follows: 0 (no perceptual quality) to 3 (severe perceptual quality).

Time frame
Baseline, 1 year
4

Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10

Patients will rate themselves from a 0 - 4 (0: no problem to 4: Severe Problem) on 10 items within the Eating Assessment Tool - 10

Time frame
Baseline, 1 year

Secondary outcomes

1

Adverse Effects in the Experimental Group

Will document the total number of adverse effects in the experimental group.

Time frame
Baseline, 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov
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